Post-marketing Safety Surveillance of Breviscapine Powder-Injection : a Registry Study

Zhong Wang

Status: Suspended

Conditions: Adverse Drug Reaction; Adverse Drug Event; Chinese Medicine; Anaphylactic Reaction

Treatments: Drug: Breviscapine Powder-Injection

Study type: Observational

Funder types: Other

Identifiers

NCT02559960

Dengzhan-V1.0

Details and patient eligibility

About

This registry aims to monitor the safety of Breviscapine Powder-Injection and to identify the potential risk factors for the adverse drug reactions.

Full description

Breviscapine Powder-Injection is a kind of natural compound injection with high purity of Scutellarin-Na (over 98%). It's a popular drug for ischemic diseases, as cerebral ischemic stroke, coronary heart disease or angor pectoris. However, more and more case reports about the adverse drug events of Chinese medicine injections extracted from Dengzhanhua (herba erigernotis) (Breviscapine is one of the most common compounds in it) have been reported in recent 10 years. Therefore, this registry of Breviscapine Powder-Injection aims to monitor the safety of Breviscapine Powder-Injection and to identify the potential risk factors for the adverse drug reactions.

Enrollment: 20,000 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients who use Breviscapine Powder-Injection in the monitoring departments of centain hospitals

Exclusion criteria

• None

Trial design

20,000 participants in 1 patient group

Breviscapine Powder-Injection

Description:

Breviscapine Powder-Injection will be given to the patients, and the investigators will record all the information including ADR, application of Breviscapine Powder-Injection and the combined medications, etc.

Treatment:

Drug: Breviscapine Powder-Injection